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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE E LEFT PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE E LEFT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Material Erosion (1214); Fracture (1260)
Patient Problems Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Swelling (2091); Tissue Damage (2104); Limited Mobility Of The Implanted Joint (2671); No Information (3190)
Event Date 09/30/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Report source: (b)(6). Customer has not indicated whether or not the product will be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that a patient was revised approximately two and half years post implantation due to implant fracture. The patient presented a secondary rupture of the patellar tendon, possibly traumatic. There is no additional information at this time.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
Multiple mdr reports were filed for this event, please see associated report: 0001822565-2019-05071. Concomitant medical products: articular surface with hinge post size e 12 mm height item# 00588005012 lot# 63516115, stem extension straight 15mm dia x 100mm length item# 00598801015 lot# 63464365. The product has been returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
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Brand NameFEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE E LEFT
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9176594
MDR Text Key161951159
Report Number0001822565-2019-04360
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
PMA/PMN Number
K013385
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2021
Device Model NumberN/A
Device Catalogue Number00588001501
Device Lot Number63384340
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2019
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 10/10/2019 Patient Sequence Number: 1
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